BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 2070575 · Received March 25, 2011

    Report

    Report Number
    2021710-2011-00022
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K022674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON FEBRUARY 23, 2011, CAREFUSION SENT A LETTER VIA E-MAIL TO THE USER FACILITY SEEKING ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT AND THE CONDITION OF THE PATIENT. AS OF MARCH 22, 2011, THERE HAS BEEN NO RESPONSE FROM THE USER FACILITY. (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE CAREFUSION FIELD SERVICE REP. THE CAREFUSION FIELD SERVICE REP EVALUATED THE DEVICE AND WAS UNABLE TO REPRODUCE/VERIFY THE COMPLAINT. THUS NO ROOT CAUSE OF THE ALLEGED MALFUNCTION WAS DETERMINED. CAREFUSION FIELD SERVICE REP. RAN THE DEVICE THROUGH A COMPLETE CHECKOUT TO ENSURE THAT IT MEETS ALL FACTORY SPECIFICATIONS AND THAT ALL ALARMS FUNCTIONED APPROPRIATELY. UPON COMPLETION, THE DEVICE WAS RETURNED TO THE USER FACILITY'S CONTROL READY TO BE PLACED BACK INTO SERVICE. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS DID NOT FIND ANY VERIFIED LIKE FAILURES, THUS CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT AND THE CONDITION OF THE PATIENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "[NAME REMOVED] CALLED IN REPORTING AN INCIDENT WHICH OCCURRED ON (B)(6) 2010, THIS VENTILATOR SHUT OFF WHILE ON A PATIENT. THIS IS THE FIRST TIME REPORTING THIS INCIDENT TO CAREFUSION, AS STATED BY [NAME REMOVED] PER THE HOSPITAL PROTOCOL, THEY MUST "RED BAG" THE UNIT AND FILE INCIDENT REPORT FIRST BEFORE REPORTING TO THE MANUFACTURING COMPANY." "DETAILS REPORTED: THE UNIT SHUT OFF WITHOUT AUDIBLE OR VISIBLE ALARMS, THIS WAS ON A NEONATE PATIENT AT THE TIME. RESPIRATORY THERAPIST WAS AT THE BEDSIDE AND PATIENT WAS BAGGED WITH 100% O2, NO COMPROMISE NOTED TO THE PATIENT, PATIENT WAS PLACED ON A REPLACEMENT VENTILATOR AFTER THE INCIDENT." "THEY COULD NOT PROVIDE SETTINGS OR SOFTWARE VERSIONS, OR NAME OF THE RESPIRATORY THERAPIST INVOLVED AT THIS TIME. BUT THE VENTILATOR HAS NOT BEEN TOUCHED SINCE THE INCIDENT OCCURRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ASKU / ASKU